RINGSIDE

• Research type

  Research Study

• Full title

  RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors

• IRAS ID

  1003680

• Sponsor organisation

  Ayala Pharmaceuticals, Inc.

• Eudract number

  2020-005833-34

• Clinicaltrials.gov Identifier

  NCT04871282

• Research summary

  This is a Phase 2/3 randomised study in participants with progressive desmoid tumours consisting of 2 parts. Part A (up to 36 participants) is an open-label study to find out which dose and schedule of taking the study drug is better for participants; Part B is a double blind study utilising the dose regimen selected in Part A. An open-label extension study, to be described as a separate protocol, is planned for participants who completed Parts A or B.
  At the moment, participants are only consenting for Part A of the study.
  Desmoid tumours are growths that occur in the connective tissue, which connects the tissues and organs in the body. Progressive means that the tumour has grown in size.
  Desmoid tumours usually do not spread to other areas of the body, but they can grow into nearby structures and organs in the body. As desmoid tumours progress or grow, they can cause problems related to where they are growing, due to pressing on other organs, cosmetic (appearance) problems and by limiting the movement of joints when they grow in the arms and legs.
  The main purpose of this study is to see if the study drug, called AL102 is safe and effective in people with progressive desmoid tumours.
  The Main portion of Part A will consist of screening, treatment, and follow-up periods. Part A will also include a food effect/pharmacokinetics (PK) sub study on the first 12 participants enrolled. These participants will continue into the Main Treatment phase during which participants will be randomised to receive one of three oral dose regimens until progression, intolerable toxicity, or withdrawal of consent.
  • AL102 1.2mg
  • AL102 2mg weekly intermittent or
  • 4mg weekly intermittent
  Part B (up to 156 participants) is a 2-arm study evaluating the recommended dose regimen from Part A in adults and adolescents (≥12 years of age). Eligible participants will be randomised to receive AL102 or placebo until progression, intolerable toxicity or withdrawal of consent.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  21/SW/0038

• Date of REC Opinion

  14 May 2021

• REC opinion

  Further Information Favourable Opinion